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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Arthritis+Rheumatol
2018 ; 70
(7
): 1071-1076
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gab.com Text
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English Wikipedia
Brief Report: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled,
Multiple-Dose Study to Evaluate AMG 557 in Patients With Systemic Lupus
Erythematosus and Active Lupus Arthritis
#MMPMID29513931
Cheng LE
; Amoura Z
; Cheah B
; Hiepe F
; Sullivan BA
; Zhou L
; Arnold GE
; Tsuji WH
; Merrill JT
; Chung JB
Arthritis Rheumatol
2018[Jul]; 70
(7
): 1071-1076
PMID29513931
show ga
OBJECTIVE: To evaluate the safety and potential efficacy of AMG 557, a fully
human antibody directed against the inducible T cell costimulator ligand (ICOSL)
in patients with systemic lupus erythematosus (SLE) with arthritis. METHODS: In
this phase Ib, randomized, double-blind, placebo-controlled study, patients
received AMG 557 210 mg (n = 10) or placebo (n = 10) weekly for 3 weeks, then
every other week for 10 additional doses. The corticosteroid dosage was tapered
to ?7.5 mg/day by day 85, and immunosuppressants were discontinued by day 29.
Primary end points on day 169 were safety, immunogenicity, the Lupus Arthritis
Response Index (LARI; defined by a reduction in the tender and swollen joint
counts), ?1-letter improvement in the musculoskeletal domain of the British Isles
Lupus Assessment Group (BILAG) index, and medication discontinuation. The
secondary/exploratory end points were changes in the tender and swollen joint
counts, BILAG index scores (musculoskeletal, global), and the Systemic Lupus
Erythematosus Disease Activity Index (SLEDAI). RESULTS: The incidence of adverse
events, most of which were mild, was similar between groups. LARI responses
occurred in 3 of 10 patients receiving AMG 557 and 1 of 10 patients receiving
placebo (P = 0.58). More patients in the AMG 557 group achieved a ?4-point
improvement in the SLEDAI score on day 169 (7 of 10 patients) compared with the
placebo group (2 of 10 patients) (P = 0.07). Patients treated with AMG 557
(versus placebo) had greater improvements from baseline in the global BILAG index
scores (-36.3% versus -24.7%) and the SLEDAI score (-47.8% versus -10.7%) and in
tender (-22.8% versus -13.5%) and swollen (-62.1% versus -7.8%) joint counts on
day 169. CONCLUSION: AMG 557 showed safety and potential efficacy, supporting
further evaluation of the clinical efficacy of ICOSL blockade in patients with
SLE.